Junel Fe 1/20

Infections: vaginal infection.

Junel Fe 24 Prescribing Information

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

On This Page

• Boxed Warning
• Indications and Usage
• Dosage and Administration
• Dosage Forms and Strengths
• Contraindications
• Warnings and Precautions
• Adverse Reactions/Side Effects
• Drug Interactions
• Use In Specific Populations
• Overdosage
• Description
• Clinical Pharmacology
• Nonclinical Toxicology
• Clinical Studies
• How Supplied/Storage and Handling
• Patient Counseling Information

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4)] .

Indications and Usage for Junel Fe 24

Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see Clinical Studies (14)] .

The efficacy of Junel Fe 24 in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated.

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Junel Fe 24 Dosage and Administration

How to Start Junel Fe 24

Junel Fe 24 is dispensed in a blister card [see How Supplied/Storage and Handling (16)] . Junel Fe 24 may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception must be used until after the first 7 consecutive days of administration.

How to Take Junel Fe 24

Table 1: Instructions for Administration of Junel Fe 24

Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)

Consider the possibility of ovulation and conception prior to initiation of this product.

• Junel Fe 24 active tablets are light yellow (Day 1 to Day 24).
• Junel Fe 24 inactive tablets are brown (Day 25 to Day 28).

• Take first light yellow active tablet without regard to meals on the first day of menses.
• Take subsequent active tablets once daily at the same time each day for a total of 24 days.
• Take one brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken.
• Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet).

For each 28-day course, take in the following order:

• Take the light yellow active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first cycle pack of Junel Fe 24.
• Take subsequent active tablets once daily at the same time each day for a total of 24 days.
• Take one brown tablet (ferrous fumarate) daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown tablets are taken.
• Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.

Switching to Junel Fe 24 from another oral contraceptive

Start on the same day that a new pack of the previous oral contraceptive would have started.

Switching from another contraceptive method to Junel Fe 24

Start Junel Fe 24:

Starting Junel Fe 24 after Abortion or Miscarriage

• After a first-trimester abortion or miscarriage, Junel Fe 24 may be started immediately. An additional method of contraception is not needed if Junel Fe 24 is started immediately.
• If Junel Fe 24 is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Junel Fe 24.

• Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Junel Fe 24 following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first 28-day course of Junel Fe 24 [see Contraindications (4) and Warnings and Precautions (5.1)].

Starting Junel Fe 24 after Childbirth

• Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Junel Fe 24 following the instructions in Table 1 for women not currently using hormonal contraception.
• If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Junel Fe 24 [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.2)].

Missed Tablets

Table 2: Instructions for Missed Junel Fe 24 Tablets

Take the tablet as soon as possible. Take the next pill at the regular time and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed.

• If two consecutive active tablets are missed in Week 1 or Week 2

Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets.

• If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time

Day 1 Start : Throw out the rest of the pack and start a new pack that same day.

Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day.

Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing 3 tablets.

Advice in Case of Gastrointestinal Disturbances

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures must be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking a light yellow tablet, handle this as a missed tablet [see Dosage and Administration (2.3) ] .

Dosage Forms and Strengths

Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP, 1 mg/0.02 mg and ferrous fumarate tablets) is available in blister packs.

Each blister pack (28 tablets) contains in the following order:

• 24 light yellow, round, flat-faced, beveled-edge, unscored (active) tablets debossed with stylized b on one side and 977 on the other side and each containing 1 mg norethindrone acetate and 0.02 mg ethinyl estradiol.
• 4 brown, round, flat-faced, beveled-edge, unscored (non-hormonal inert) tablets debossed with stylized b on one side and 247 on the other side and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

Contraindications

Junel Fe 24 is contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
  • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
  • Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
  • Have cerebrovascular disease [see Warnings and Precautions (5.1)]
  • Have coronary artery disease [see Warnings and Precautions (5.1)]
  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
  • Have uncontrolled hypertension [see Warnings and Precautions (5.4)]
  • Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.6)]
  • Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions (5.7)]
    • Women over age 35 with any migraine headaches [see Warnings and Precautions (5.7)]

    Warnings and Precautions

    Thrombotic Disorders and Other Vascular Problems

    • Stop Junel Fe 24 if an arterial thrombotic event or venous thromboembolic (VTE) event occurs.
    • Stop Junel Fe 24 if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately [see Adverse Reactions (6.2)].
    • If feasible, stop Junel Fe 24 at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during the following prolonged immobilization.
    • Start Junel Fe 24 no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
    • The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs. The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COCs and when restarting oral contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
    • Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). This risk increases with age, particularly in women over 35 years of age who smoke.
    • Use COCs with caution in women with cardiovascular disease risk factors.

    Liver Disease

    Impaired Liver Function
    Do not use Junel Fe 24 in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4)] . Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue Junel Fe 24 if jaundice develops.

    Liver Tumors
    Junel Fe 24 is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases per 100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage.

    Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the risk of liver cancers in COC users is less than one case per million users.

    Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment

    During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Junel Fe 24 prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4)] . Junel Fe 24 can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

    High Blood Pressure

    Junel Fe 24 is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)] . For women with well-controlled hypertension, monitor blood pressure and stop Junel Fe 24 if blood pressure rises significantly.

    An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

    Gallbladder Disease

    Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis.

    Carbohydrate and Lipid Metabolic Effects

    Carefully monitor prediabetic and diabetic women who are taking Junel Fe 24. COCs may decrease glucose tolerance.

    Consider alternative contraception for women with uncontrolled dyslipidemias. A small proportion of women will have adverse lipid changes while on COCs.

    Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.

    Headache

    If a woman taking Junel Fe 24 develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Junel Fe 24 if indicated.

    Consider discontinuation of Junel Fe 24 in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).

    Bleeding Irregularities and Amenorrhea

    Unscheduled Bleeding and Spotting
    Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product.

    In a clinical trial of Junel Fe 24, the frequency and duration of unscheduled bleeding and/or spotting was assessed in 743 women (3,823 28-day cycles). A total of 10 subjects (1.3%) discontinued Junel Fe 24, at least in part, due to bleeding or spotting. Based on data from the clinical trial, [24 to 38%] of women using Junel Fe 24 experienced unscheduled bleeding per cycle in the six months of the trial. The percent of women who experienced unscheduled bleeding tended to decrease over time.

    Amenorrhea and Oligomenorrhea
    Women who use Junel Fe 24 may experience absence of withdrawal bleeding, even if they are not pregnant. In the clinical trial with Junel Fe 24, 31 to 41% of the women using Junel Fe 24 did not have a withdrawal menses in at least one of 6 cycles of use.

    Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was preexistent.

    If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.

    COC Use Before or During Early Pregnancy

    Extensive epidemiologic studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when oral contraceptives are taken inadvertently during early pregnancy. Discontinue Junel Fe 24 use if pregnancy is confirmed.

    Administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy [see Use in Specific Populations (8.1)].

    Depression

    Carefully observe women with a history of depression and discontinue Junel Fe 24 if depression recurs to a serious degree.

    Malignant Neoplasms

    Junel Fe 24 is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4)].

    Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (

    Effect on Binding Globulins

    The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormone or cortisol therapy may need to be increased.

    Monitoring

    A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.

    Hereditary Angioedema

    In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

    Chloasma

    Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking Junel Fe 24.

    Adverse Reactions

    The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

    • Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)]
    • Vascular events [see Warnings and Precautions (5.1)]
    • Liver disease [see Warnings and Precautions (5.2)]

    Adverse reactions commonly reported by COC users are:

    • Irregular uterine bleeding
    • Nausea
    • Breast tenderness
    • Headache

    Clinical Trial Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    The safety of Junel Fe 24 was evaluated in 743 subjects who participated in an open-label, randomized, active-controlled, multicenter clinical trial of Junel Fe 24 for contraception. This trial examined healthy, non-pregnant volunteers aged 18 to 45 years, who were sexually active and had a body mass index of ≤ 35 kg/m 2 . Subjects were followed for up to six 28-day cycles providing a total of 3,823 treatment-cycles of exposure.

    Common Adverse Reactions (≥ 2% of all subjects) : The most common adverse reactions reported by at least 2% of the 743 women using Junel Fe 24 were the following, in order of decreasing incidence: headache (6.3%), vaginal candidiasis (6.1%), nausea (4.6%), menstrual cramps (4.4%), breast tenderness (3.4%), mood changes (including mood swings (2.2%) and depression (1.1%), bacterial vaginitis (3.1%), acne (2.7%), and weight gain (2.0%).

    Adverse Reactions Leading to Study Discontinuation : Among the 743 women using Junel Fe 24, 46 women (6.2%) withdrew because of an adverse event. Adverse events occurring in 3 or more subjects leading to discontinuation of treatment were, in decreasing order: abnormal bleeding (0.9%), nausea (0.8%), mood changes (0.8%), menstrual cramps (0.4%), increased blood pressure (0.4%), and irregular bleeding (0.4%).

    Postmarketing Experience

    Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 to 1.12 (Figure 1).

    Figure 1: Risk of Breast Cancer with Combined Oral Contraceptive Use

    RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

    The following adverse reactions have been identified during post approval use of Junel Fe 24. Because these reactions are reported voluntarily from a population of uncertain size, it is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.

    Cardiovascular: chest pain, palpitations, tachycardia, angina pectoris, myocardial infarction.

    Endocrine disorders: hypothyroidism, hyperthyroidism.

    Eye disorders: blurred vision, visual impairment, transient blindness, corneal thinning, change in corneal curvature (steepening).

    GI disorders: nausea, vomiting, abdominal pain, constipation, pancreatitis.

    Hepatobiliary disorders: cholelithiasis, cholecystitis, hepatic adenoma, hemangioma of liver.

    Immune system disorders: anaphylactic reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

    Infections: vaginal infection.

    Metabolism and nutrition disorders: change in weight or appetite (increase or decrease).

    hypoglycemia, diabetes mellitus, anemia.

    Musculoskeletal and connective tissue disorders: myalgia.

    Skin and subcutaneous disorders: alopecia, rash (generalized and allergic), pruritus, skin discoloration, night sweats, swelling face or lips, hirsutism, skin burning sensation, erythema multiforme, erythema nodosum, hemorrhagic eruption.

    Nervous system disorders: headache, dizziness, migraine, hyperesthesia, paraesthesia, hypoaesthesia, somnolence, loss of consciousness, sensory disturbance.

    Psychiatric disorders: mood swings, depression, insomnia, anxiety, suicidal ideation, panic attack, changes in libido, bipolar disorder, dissociation, homicidal ideation.

    Renal and urinary disorders: pollakiuria, dysuria, cystitis-like syndrome.

    Reproductive system and breast disorders: breast changes (tenderness, pain, enlargement, and secretion), premenstrual syndrome, ovarian cyst, pelvic pain, ovarian cyst ruptured, pelvic fluid collection.

    Vascular disorders: hot flush, thrombosis/embolism (coronary artery, pulmonary, cerebral, deep vein), migraine, transient ischemic attack, ischemic stroke.

    Drug Interactions

    Consult the labeling of concurrently used drugs to obtain further information about interactions with oral contraceptives or the potential for enzyme alterations.

    Effects of Other Drugs on Combined Oral Contraceptives

    Substances decreasing the plasma concentrations of COCs and potentially diminishing the efficacy of COCs:

    Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of COCs and potentially diminish the effectiveness of COCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of oral contraceptives including phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between COCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with COCs, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

    Substances increasing the plasma concentrations of COCs:

    Coadministration of atorvastatin or rosuvastatin and certain COCs containing ethinyl estradiol (EE) increase AUC values for EE by approximately 20 to 25%. Ascorbic acid and acetaminophen may increase plasma EE concentrations, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma hormone concentrations.

    Human immunodeficiency virus (HIV)/Hepatitis C virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

    Significant changes (increase or decrease) in the plasma concentrations of estrogen and/or progestin have been noted in some cases of coadministration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritnoavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine] or increase [e.g., etravirine]).

    Effects of Combined Oral Contraceptives on Other Drugs

    COCs containing EE may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. COCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid, and temazepam. Significant decrease in plasma concentration of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary.

    Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because the serum concentration of thyroid-binding globulin increases with use of COCs [see Warnings and Precautions (5.12)] .

    Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation

    Do not coadminister Junel Fe 24 with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.3)] .

    Interactions with Laboratory Tests

    The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    There is no use for contraception in pregnancy; therefore, Junel Fe 24 should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy.

    In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.

    Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy.

    Lactation

    Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding [see Dosage and Administration (2.2).] The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and any potential adverse effects on the breastfed child from norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets or from the underlying maternal condition.

    Pediatric Use

    Safety and efficacy of Junel Fe 24 have been established in women of reproductive age. Efficacy is expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.

    Geriatric Use

    Junel Fe 24 has not been studied in postmenopausal women and is not indicated in this population.

    Hepatic Impairment

    The pharmacokinetics of Junel Fe 24 has not been studied in subjects with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [see Contraindications (4) and Warnings and Precautions (5.2)].

    Renal Impairment

    The pharmacokinetics of Junel Fe 24 has not been studied in women with renal impairment.

    Body Mass Index

    The safety and efficacy of Junel Fe 24 in women with a body mass index (BMI) > 35 kg/m 2 has not been evaluated [see Clinical Studies (14)].

    Overdosage

    There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

    Junel Fe 24 Description

    Junel ® Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets) is a combination oral contraceptive for oral administration consisting of 24 light yellow active tablets containing norethindrone acetate, USP, a progestin, and ethinyl estradiol, USP, an estrogen, and 4 brown inert tablets containing ferrous fumarate, which serve no therapeutic purpose.

    • Each light yellow tablet contains 1 mg norethindrone acetate, USP and 0.02 mg ethinyl estradiol, USP. Each light yellow tablet also contains the following inactive ingredients: acacia, compressible sugar, D&C yellow no. 10 aluminum lake, lactose monohydrate, magnesium stearate and pregelatinized corn starch.
    • Each brown tablet contains 75 mg ferrous fumarate, crospovidone, hydrogenated vegetable oil and microcrystalline cellulose. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay.

    The chemical name of ethinyl estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol, and the structural formula is:

    C 20 H 24 O 2 M.W. 296.40

    The chemical name of norethindrone acetate, USP is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one acetate, and the structural formula is:

    C 22 H 28 O 3 M.W. 340.46

    Junel Fe 24 – Clinical Pharmacology

    Mechanism of Action

    CHCs prevent pregnancy primarily by suppressing ovulation.

    Pharmacodynamics

    No specific pharmacodynamic studies were conducted with Junel Fe 24.

    Pharmacokinetics

    Norethindrone acetate appears to be completely and rapidly deacetylated to norethindrone after oral administration, because the disposition of norethindrone acetate is indistinguishable from that of orally administered norethindrone. Norethindrone acetate and ethinyl estradiol are rapidly absorbed from Junel Fe 24 tablets, with maximum plasma concentrations of norethindrone and ethinyl estradiol occurring 1 to 4 hours postdose. Both are subject to first-pass metabolism after oral dosing, resulting in an absolute bioavailability of approximately 64% for norethindrone and 43% for ethinyl estradiol.

    The plasma norethindrone and ethinyl estradiol pharmacokinetics following single- and multiple-dose administrations of Junel Fe 24 tablets in 17 healthy female volunteers are provided in Figures 2 and 3, and Table 3.

    Following multiple-dose administration of Junel Fe 24 tablets, mean maximum concentrations of norethindrone and ethinyl estradiol were increased by 95% and 27%, respectively, as compared to single-dose administration. Mean norethindrone and ethinyl estradiol exposures (AUC values) were increased by 164% and 51% respectively, as compared to single-dose administration of Junel Fe 24 tablets.

    Steady-state with respect to norethindrone was reached by Day 17 and steady-state with respect to ethinyl estradiol was reached by Day 13.

    Mean SHBG concentrations were increased by 150% from baseline (57.5 nmol/L) to 144 nmol/L at steady-state.

    Figure 2. Mean Plasma Norethindrone Concentration-Time Profiles Following Single- and Multiple-Dose Oral Administration of Junel Fe 24 Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)

    Figure 3. Mean Plasma Ethinyl Estradiol Concentration-Time Profiles Following Single- and Multiple-Dose Oral Administration of Junel Fe 24 Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)

    Table 3. Summary of Norethindrone (NE) and Ethinyl Estradiol (EE) Pharmacokinetics Following Single- and Multiple-Dose Oral Administration of Junel Fe 24 Tablets to Healthy Female Volunteers Under Fasting Condition (n = 17)

    Arithmetic Mean a (% CV) by Pharmacokinetic Parameter

    Junel Fe 1/20

    Generic name: Ethinyl Estradiol, Norethindrone, and Ferrous Fumarate [ ETH-in-il-es-tra-DYE-ole, nor-eth-IN-drone, & FER-uhs-FYOO-mar-rate ]
    Brand names: Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi Fe 1/20, Estrostep Fe, Gildess 24 Fe, . show all 25 brands Gildess Fe 1.5/30, Gildess Fe 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Junel Fe 24, Larin 24 Fe, Larin Fe 1.5/30, Larin Fe 1/20, Lo Loestrin Fe, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Lomedia 24 Fe, Microgestin 24 Fe, Microgestin Fe 1.5/30, Microgestin Fe 1/20, Tarina Fe 1/20, Taytulla, Tilia Fe, Tri-Legest Fe
    Drug classes: Contraceptives, Sex hormone combinations

    Medically reviewed by Drugs.com. Last updated on Dec 23, 2022.

    Warning

    • Smoking cigarettes while using Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) raises the chance of very bad heart and blood-related side effects. This chance is raised with age (mainly in women older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) if you smoke and are older than 35 years of age.

    Uses of Junel Fe 1/20:

    • It is used to prevent pregnancy.
    • It is used to treat pimples (acne).
    • It may be given to you for other reasons. Talk with the doctor.

    What do I need to tell my doctor BEFORE I take Junel Fe 1/20?

    • If you are allergic to Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate); any part of Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
    • If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer or other cancer where hormones make it grow, diseased blood vessels in the brain or heart, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, liver disease, liver tumor, very bad headache or migraine, or diabetes that affects blood flow.
    • If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
    • If you are taking ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
    • If you are pregnant or may be pregnant. Do not take Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) if you are pregnant.
    • If you are breast-feeding or plan to breast-feed.
    • If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
    • If your child has not had her first period.

    This is not a list of all drugs or health problems that interact with Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate).

    Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

    What are some things I need to know or do while I take Junel Fe 1/20?

    • Tell all of your health care providers that you take Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate). This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) is stopped, your doctor will tell you when to start taking Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) again after your surgery or procedure.
    • This medicine may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.
    • Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
    • Some studies have shown the risk of breast cancer is raised in women taking birth control pills, especially at a younger age. The risk was also linked to how long the birth control pills were taken. One study showed the risk was also raised in women who took birth control pills within the past 10 years.
    • If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
    • Check your blood sugar as you have been told by your doctor.
    • High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
    • Have blood work checked as you have been told by the doctor. Talk with the doctor.
    • Be sure to have regular breast exams and gynecology check-ups. You will also need to do breast self-exams as you have been told.
    • If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
    • If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
    • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate).
    • Certain drugs, herbal products, or health problems could cause Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) to not work as well. Be sure your doctor knows about all of your drugs and health problems.
    • This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
    • This medicine may raise the chance of blood clots. The chance is highest during the first year of using Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate). The chance is also highest when starting to use hormone-based birth control again after not using it for 4 weeks or more. Talk with the doctor.
    • If you are taking Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) for pimples (acne), you need to be at least 15 years of age.
    • If you have any signs of pregnancy or if you have a positive pregnancy test, call your doctor right away.

    How is this medicine (Junel Fe 1/20) best taken?

    Use Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

    • Take Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) at the same time of day.
    • Take with or without food. Take with food if it causes an upset stomach.
    • If you also take colesevelam, take it at least 4 hours before or after you take Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate).
    • After starting Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate), you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about using a non-hormone type of birth control.
    • Do not skip doses, even if you do not have sex very often.
    • If you throw up or have diarrhea, Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) may not work as well to prevent pregnancy. Use an extra form of birth control, like condoms, until you check with your doctor.
    • If you miss 2 periods in a row, take a pregnancy test before starting a new cycle.

    What do I do if I miss a dose?

    • If a dose is missed, check the package insert or call the doctor to find out what to do. If using Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate) to prevent pregnancy, another form of birth control may need to be used for some time to prevent pregnancy.

    What are some side effects that I need to call my doctor about right away?

    WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

    • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
    • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
    • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
    • Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or very upset stomach or throwing up.
    • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
    • Depression or other mood changes.
    • Swelling.
    • A lump in the breast, breast pain or soreness, or nipple discharge.
    • Vaginal itching or discharge.
    • Eyesight changes or loss, bulging eyes, or change in how contact lenses feel.
    • Spotting or vaginal bleeding that is very bad or does not go away.
    • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

    What are some other side effects of Junel Fe 1/20?

    All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

    • Feeling more or less hungry.
    • Weight gain or loss.
    • Dizziness or headache.
    • Upset stomach or throwing up.
    • Stomach cramps.
    • Bloating.
    • Enlarged breasts.
    • Tender breasts.
    • This medicine may cause dark patches of skin on your face. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
    • Period (menstrual) changes. These include lots of bleeding, spotting, or bleeding between cycles.

    These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

    You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

    If OVERDOSE is suspected:

    If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

    How do I store and/or throw out Junel Fe 1/20?

    • Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
    • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
    • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

    Consumer Information Use and Disclaimer

    • If your symptoms or health problems do not get better or if they become worse, call your doctor.
    • Do not share your drugs with others and do not take anyone else’s drugs.
    • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Junel Fe 1/20 (ethinyl estradiol, norethindrone, and ferrous fumarate), please talk with your doctor, nurse, pharmacist, or other health care provider.
    • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

    More about Junel Fe 1 / 20 (ethinyl estradiol / norethindrone)

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    • During pregnancy
    • Drug class: contraceptives

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